Where To Buy Cefaly Migraine Device
The U.S Food and Drug Administration (FDA) has cleared the CEFALY medical device as an over-the-counter (OTC) product for the acute and preventative treatment of migraine headaches in adults 18 years of age and older. CEFALY can be purchased without a prescription at www.cefaly.com.
where to buy cefaly migraine device
CEFALY becomes the first dual-purpose, external Trigeminal Nerve Stimulator (eTNS) device for migraine headaches available OTC in the United States. The OTC designation means the FDA has confirmed that CEFALY is safe and effective for use by members of the general public who have been diagnosed with migraine by a physician.
CEFALY is a single device with two treatment options: Program 1, a 60-minute ACUTE setting that provides pain relief at the onset of a migraine, and Program 2, a 20-minute PREVENT setting for daily use to help prevent future episodes.
CEFALY is the #1 FDA cleared drug free migraine treatment that can help improve your quality of life and free you from migraine pain. With no prescription needed, this simple-to-use medical device works to treat acute migraine attacks quickly, prevent future episodes, and may cut your number of migraine days by almost half.
CEFALY gets to the root of the problem by limiting pain signals from the areas where migraine headaches start. The CEFALY technology acts directly on the pathways involved in migraines to significantly relieve pain and prevent future migraine attacks.
A lot of people want to use non-drug approaches to help manage their migraine symptoms. There are a range of medical devices which may be beneficial for headache or migraine symptoms. Below is an overview of the devices currently available in the UK.
Most headaches and migraine involve the trigeminal nerve. The trigeminal nerve is a nerve in the head, part of which runs around above your eye. This is the part of the trigeminal nerve that is stimulated by the Cefaly device.
In May 2016 the National Institute for Health and Care Excellence (NICE) published guidance on the use of a transcutaneous electrical stimulation of the supraorbital nerve for treating and preventing migraine, in relation to the Cefaly device. NICE found that there were no major safety concerns, but the evidence for the effectiveness of Cefaly was limited. The NICE recommendation is that Cefaly should only be used with special arrangements for clinical governance, consent and audit or research. If you are interested in trying Cefaly, speak to your doctor initially.
sTMS is a non-invasive and non-drug treatment for migraine. It involves placing the sTMS device against the back of your head for a second to deliver a very brief pre-set magnetic pulse. The device is called sTMS mini. It is portable, rechargeable and reusable. It is activated on a regular basis (usually every 3 months) with a prescription.
The sTMS mini device is placed at the back of the head for less than a minute, generating a magnetic pulse that forms a mild electric current at the back of the brain. The number of pulses can be repeated as prescribed by your neurologist. The pulse is painless and generates mild currents in the brain tissue that are believed to interrupt the brain activity linked to migraine. sTMS is painless and causes no serious side effects.
In early March 2014, the FDA approved for use a transcutaneous electrical nerve stimulation device for the prevention of migraine, known as Cefaly. Since the FDA approval, many news outlets have been reporting on the availability of the device and many patients have been inquiring about the efficacy of the device and whether it is right for them.
The FDA approval was based upon two studies that showed safety and tolerability of the device, with the smaller of the two studies showing a modest benefit in the reduction of days per month with migraine and less migraine medication usage than those who were using the placebo device.
This study was small, including only 67 patients with an average of nearly seven migraine days per month. The study found a statistically significant difference between the active device and placebo device with patients using the active device seeing a reduction of migraine days per month from nearly seven days per month to just under five days per month.1
A larger survey study was conducted of 2,313 migraine patients who rented the device for a 40-day period. This study found that 54% of patients were satisfied with the device and willing to purchase it.2 In both studies, there were not any serious adverse events, and most adverse events were minor.
Thus far, there has been a huge public awareness of the availability of this device and to me that is the most exciting aspect of the Cefaly FDA approval. This reaffirms the message to clinicians and researchers that patients with migraine are in need of additional treatment options and are quite receptive to new potential treatment options.
Although many patients also report benefit from using the device during migraine attacks, only limited data is available on the efficiency of Cefaly for attack treatment. In a pilot trial of ten episodic migraine patients who treated three attacks with the device [3], total relief without rescue medication was reported in 12% of attacks, incomplete relief with rescue medication in 42.5% and no effect in 45.5%. In an open study including 16 patients, the Cefaly device was effective and well tolerated as rescue therapy for migraine attack symptoms present since at least 72 h and reduced the headache on average by 46% [4].
While awaiting the results of larger controlled trials, useful information might be obtained by interviewing migraineurs who apply the device for migraine prevention about its use during attacks and ability to reduce acute anti-migraine drug intake. We conducted, therefore, a survey on 807 Belgian, Swiss and French subjects from the Cefaly customer database who were identified as regular users because they had purchased the device and ordered new electrodes within the last year. One of us (JS) invited them by email to answer on-line an eight-item questionnaire, using the SurveyMonkey [5] service provider to implement the survey and collect the results. Confidentiality was guaranteed by fully disabling the electronic and IP addresses recordings in order to collect anonymous responses.
The primary outcome measure was the mean number of acute anti-migraine drug intake avoided per month per patient thanks to the use of Cefaly. Secondary outcome measures were: percentage of subjects using the device during an attack, percentage of attacks treated with the device, percentage of Cefaly-treated attacks with reduction of acute anti-migraine drugs.
The results are displayed in Table 1. Among the 413 regular device users for prevention, 88.6% also used it as an acute treatment in 71.8% of their attacks. In 42.6% of these attacks the use of Cefaly was accompanied by reduced intake of acute anti-migraine medications. For the total cohort, Cefaly allowed to reduce acute migraine drug intake on average in 2.93 attacks per month per subject. If only those 366 subjects using the device for attack treatment are considered, this number increases to 3.31 attacks per month per subject. This represents the lower bound of the actual numerical reduction in drug intake, since for one attack multiple intakes can occur.
Clinical practice indicates that many migraine patients who purchased the Cefaly also use it during attacks, but that 88.6% of them would do so was not expected. This may be due to the user manual that recommends program 1 for attack treatment, besides program 2 for prevention. According to our survey, program 1 allows reducing specific and non-specific acute migraine drug consumption in 42.6% of attacks in more than 80% of subjects. Admittedly, this is not a direct measure of the effect of Cefaly on migraine attacks, but the high proportion of ictal users and attacks treated per subject (71.8%) suggests that the device is consistently beneficial. Moreover, the reduction of acute medication intake of 3.31 per subject per month has pharmaco-economic importance and reduces the chronifying risk of medication overuse in patients with frequent migraine.
NEW YORK, March 17, 2020 /PRNewswire/ -- CEFALY, the first device of its kind to receive FDA medical clearance for migraine headaches announced a Buy Back program today where customers in the United States and Canada may return their original CEFALY 1 device (C1) and receive a discount off the purchase of a CEFALY DUAL device.
The CEFALY DUAL offers two distinct treatment options -- a 60-minute ACUTE setting that serves as an abortive treatment for pain relief at the onset of a migraine, which is clinically proven to stop or reduce migraine pain during an attack; and a 20-minute PREVENT setting for daily use to help prevent future episodes. The Buy Back program offers users already accustomed to the CEFALY treatment an opportunity to swap their device and pay the difference to upgrade to a the CEFALY DUAL. The new device will again come with a renewed 60-day money back guarantee.
"We are excited to provide a program where customers already familiar with the many benefits of CEFALY can upgrade their existing device and benefit from the latest in migraine treatment technology and a new compact device with two program options," said Jennifer Trainor-McDermott, CEO with CEFALY Technology.
CEFALY has rapidly become a global brand, widely recognized among the migraine community, which is estimated to be around 1 billion worldwide1. The non-invasive device is placed on the forehead to stimulate and desensitize the area research identifies as a center for migraine pain, the Trigeminal nerve. Since CEFALY is not a drug, it can be used as a standalone option or with an existing treatment. Customers who use the device consistently show a decrease in migraine days and a reduced use of migraine medication.
To participate in the Buy Back program eligible users in the United States will receive a $150 USD discount code to purchase a CEFALY DUAL device. For more information visit: -trade-in-program. In Canada, eligible users will receive a CA$50 discount code to purchase a CEFALY DUAL device. For more information visit: -ca/cefaly-c1-device-trade-in-program 041b061a72